Course overview
This intensive one-day course will introduce those who are new to medical device design and development to the critical elements of the human factors and usability engineering process. The programme shall cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.
The key regulations of the Medical Device Regulation and In-vitro Diagnostic Regulation, the Code of Federal Regulations from the USA (CFR 820.30 and Titles 50 and 56) and the UK MHRA Guidance for Human Factors and Usability Engineering shall be described, along with the specific processes and tools used in IEC 62366-1 and other ISO standards specific to special medical devices. A focus on ethics, consent and user safety shall be described, along with how ISO 14971:2019 is used alongside any human factors process.
The key areas of user research and design inputs shall be described along with verification and validation activities - formative and summative human factors studies and tests so that their purpose, methodology, process and outcomes are understood. Post-market surveillance human factors shall also be detailed since this area is becoming increasingly important to include. Finally, a basic understanding of ergonomics, anthropometry, user experience and biomechanics shall be detailed before an end of the day discussion on the wider use of human factors and usability engineering shall be discussed.
Attending this event will provide delegates with a comprehensive appraisal of key aspects of human factors in medical device design and an opportunity to discuss the complexities involved with an experienced industry expert.
CPD Hours: 6
Speakers
Greg Thay
Greg Thay is owner and founder of THAY Medical, a Human Factors and Usability Engineering consultancy based in the UK and in Europe. He has worked in Human Factors since 2008 and has practised this specialism on many medical devices of all types. He has interviewed and evaluated thousands of people of all healthcare disciplines all over the world and completed many medical device developments from the human factors perspective.
Prior to human factors, Greg gained experience in orthopaedic device development, infusion therapy device development, wound care and superconductivity product development for large and small manufacturers. Since branching out into consultancy in 2010, he has grown his knowledge of design controls and human factors to ensure that he can train his staff to be competent in this field of human factors and usability engineering.
